Keller Medical Specialties Products, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Keller Medical Specialties Products, Inc.” (first 1990, latest 1999), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 92 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 2 | 2 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| DSJ | Alarm, Blood-Pressure | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
Review panels
- Cardiovascular (4)
- Anesthesiology (2)
Most recent Keller Medical Specialties Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990648 | KELLER VITAL SIGNS MONITOR, KMS 890+ | DXN | 1999-08-10 | 162 |
| K982331 | KELLER PULSE OXIMETER, MODEL 850+ | DQA | 1998-09-11 | 71 |
| K914576 | KELLER CARDIAC MONITOR MEDIL KMS870 | DRT | 1991-12-30 | 76 |
| K910262 | KELLER VITAL SIGNS MONITOR - KMS-890 | DSJ | 1991-04-01 | 69 |
| K903437 | DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER | DRO | 1990-11-16 | 108 |
| K895987 | KELLER PULSE OXIMETER - KMS 850 | DQA | 1990-02-22 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named Keller Medical Specialties Products, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Keller Instruments, Inc. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Keller Medical Specialties Products, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Keller Medical Specialties Products, Inc.” (first 1990, latest 1999), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Keller Medical Specialties Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Keller Medical Specialties Products, Inc. is 92 days.
Which FDA product codes appear under Keller Medical Specialties Products, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 2); DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), 1); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 1).
Next steps
- See all 6 Keller Medical Specialties Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Keller Medical Specialties Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.